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Regulatory CMC Manager
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Support, Client
Projektbeschreibung
Regulatory CMC Manager wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- University degree in relevant field
- At least 5 years' of professionalism in RegCMC with extensive production knowledge
- Ability to identify needs and contribute in cross-site initiatives as applicable within and beyond the site context to improve and elaborate processes eg addressing gaps and/or achieving improvements in change control process
- A Profound background in the pharmaceutical sector would be beneficial
- Languages: fluent English and German both written and spoken
YOUR TASKS:
- Collaborating with RA CMC and RA in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3)
- Coaching, training and developing the site's personnel on regulatory specific aspects of change management and regulatory intelligence information
- Facilitating timely provision of good quality source documentation, involving co-authoring as applicable and accurate comments from technical experts to RA CMC while ensuring regulatory compliance, quality oversight and adherence to best practices
- Ensuring on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA) requests for site specific products
- Addressing and resolving issues related to regulatory compliance checks, maintaining an oversight of any compliance remediation activities at the site, ensuring appropriate handling and prompt completion of remediation activities
START: ASAP
DURATION: 8MM+
LOCATION: Basel, Switzerland
REF.NR.: BH11701
Does this sound like an interesting and challenging opportunity to you?
Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND?
In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
YOUR EXPERIENCE/SKILLS:
- University degree in relevant field
- At least 5 years' of professionalism in RegCMC with extensive production knowledge
- Ability to identify needs and contribute in cross-site initiatives as applicable within and beyond the site context to improve and elaborate processes eg addressing gaps and/or achieving improvements in change control process
- A Profound background in the pharmaceutical sector would be beneficial
- Languages: fluent English and German both written and spoken
YOUR TASKS:
- Collaborating with RA CMC and RA in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3)
- Coaching, training and developing the site's personnel on regulatory specific aspects of change management and regulatory intelligence information
- Facilitating timely provision of good quality source documentation, involving co-authoring as applicable and accurate comments from technical experts to RA CMC while ensuring regulatory compliance, quality oversight and adherence to best practices
- Ensuring on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA) requests for site specific products
- Addressing and resolving issues related to regulatory compliance checks, maintaining an oversight of any compliance remediation activities at the site, ensuring appropriate handling and prompt completion of remediation activities
START: ASAP
DURATION: 8MM+
LOCATION: Basel, Switzerland
REF.NR.: BH11701
Does this sound like an interesting and challenging opportunity to you?
Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND?
In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Sonstiges